The present invention relates to an apparatus and a method to treat a disease process in a luminal structure. Such a structure includes, but is not limited to, veins, arteries, bypass graft prostheses, the gastrointestinal (GI) tract, the biliary tract, the genitourinary (GU) tract, and the respiratory tract (e.g. the tracheobronchial tree).
Within this application several publications are referenced by Arabic numerals within parentheses. Full citations for these references may be found at the end of the specification immediately preceding the claims. The disclosures of all of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains.
Percutaneous transluminal coronary angioplasty (xe2x80x9cPCTAxe2x80x9d) is commonly used in the treatment of coronary artery obstruction, with over 400,000 procedures performed annually. The process involves the insertion of balloon catheters through the femoral artery to the targeted coronary artery. Injection of radio-opaque contrast into the proximal coronary artery allows fluoroscopic localization of stenosed coronary segments. Balloon catheters are advanced to the site of stenosis over extremely thin guide wires to position the catheter at the point of occlusion. The distal end of the catheter contains a balloon which is inflated for 2-4 minutes to the full diameter of the occluded artery, decreasing the blockage and improving blood flow.
Approximately 40% of patients undergoing this procedure have angiographic evidence of restenosis by 12 months. The biological processes responsible for restenosis are not fully understood, but appear to result from abnormal proliferation of the xe2x80x9cinsultedxe2x80x9d smooth muscle cells and neointima formation in the segment of treated artery (6). Although coronary artery blockage is a non-malignant disease, it has been suggested that treatment of the internal vessel walls with ionizing radiation could inhibit cell growth, and delay or even prevent restenosis (4, 7, 10-13).
As stated above, restenosis after arterial intervention in general, PTCA in particular, seem to be primarily due to medial smooth muscle cell proliferation. Conventional PTCA is performed using a balloon catheter such an over-the-wire type catheter manufactured, for example, by Scimed Life Systems, Inc, of Maple Grove, Minn. or a mono-rail type catheter manufactured, for example, by Advanced Cardiovascular Systems, Inc, of Temecula, Calif. FIG. 1 depicts such a conventional over-the-wire balloon catheter 1. The conventional balloon catheter 1 is utilized in an angioplasty procedure as follows. A conventional guidewire 2 is inserted into the patient""s artery until the distal end of the guidewire 2 is past a target area (not shown) of the artery (not shown) where there is a buildup of material. The conventional balloon catheter 1 has a lumen 3 running therethrough. The guidewire 2 is inserted into the distal end of the balloon catheter 1 and the balloon catheter 1 is advanced over the guidewire until the balloon section 1a of the balloon catheter 1 is adjacent the buildup of material. The balloon section 1a is then inflated by an inflation means (not show) connected to an inflation port 1b to clear the artery. Finally, the balloon section 1a is deflated, the balloon catheter 1 is pulled back up the guidewire and removed and the guidewire is likewise removed from the patient""s artery.
Current technology contemplates two distinct design classes for devices for the prevention of restenosis after arterial interventions. The first design class, an arterial stent type device, is designed for long term deployment within the artery. Such a stent, if designed to emit radiation, would be in place long after the time necessary for the prevention of smooth muscle cell proliferation at the arterial site. U.S. Pat. No. 5,059,166 to Fischell describes such a long term stent.
The second design class for restenosis preventing devices contemplates the delivery of unspecified doses of radiation via radioactive catheters and guidewires. These devices utilize a movable, flexible radiation shield. However, it is questionable whether such a radiation shield could be constructed given the thickness of material required to shield the radiation source and the flexibility required to allow delivery of the radiation source and shield to the coronary site. U.S. Pat. No. 5,213,561 to Weinstein relates to a device of this class.
In addition, neither class of devices addresses the need to isolate the radioactive source from contact with the patient""s body fluids.
In a related area, brachytherapy involves the placement of a radioactive source within tissue to deliver localized radiation and is frequently applied to treat recurrent disease in an area previously treated by external beam radiation. Blind-end catheters may be used to deliver radiation to tumors in the esophagus, trachea, or rectum, for example. Advantages include the sparing of critical structures close to the tumor, and brevity of treatment (hours to days). Difficulties primarily involve anatomic constrains on implant placement. Common applications include the endoluminal treatment of recurrent endobronchial and bile duct tumors, the intracavitary treatment of cervical and endometrial cancer, and interstitial implants in unrespectable tumors with catheters or radioactive seeds.
It is an object of the present invention to provide an arrangement for reducing restenosis after arterial or vascular intervention in a patient. Such intervention includes, but is not limited to, balloon angioplasty, atherectomy, stent placement, arterial grafts, and arteriovenous fistula.
Moreover, it is noted that long term hemodialysis therapy is complicated by thrombosis of both hemodialysis grafts and native shunts. Late graft failure (after about 6 weeks) is commonly associated with anatomic stenosis at the venous anastomosis, within the graft, or more proximally in the central venous system. Irradiation of the proliferative tissue from an intravascular source will inhibit the development of shunt outflow stenosis and thus decrease the incidence of thrombosis from the ensuing low flow state. Any proliferative tissue at the site of a vascular graft would also be amenable to this treatment.
It is a further object of the present invention to provide an arrangement for reducing restenosis after vascular intervention in the patient by delivering a precise dosage of radiation to the patient""s artery at a target area.
It is a further object of the present invention to provide an arrangement for reducing restenosis after vascular intervention in the patient by delivering precise radioactive dosage to the patient""s artery at a target area while eliminating contact between the radioactive source and the patient""s body fluids.
It is a further object of the present invention to provide an arrangement for reducing restenosis after vascular intervention in the patient by delivering a precise radioactive dosage to the patient""s artery at a target area while shielding a doctor and other staff from over-exposure to radiation.
It is another object of the present invention to provide an arrangement and method for treating a disease process or processes in a luminal structure or structures. Such structure or structures include, but are not limited to, veins, arteries, bypass graft prostheses, the gastrointestinal (GI) tract, the biliary tract, the genitourinary (GU) tract, and the respiratory tract (e.g. the tracheobronchial tree). The diseases to be treated by the invention include proliferative diseases (both malignant and non-malignant).
According to one aspect of the present invention, an apparatus guided by a guidewire within a patient""s artery for reducing restenosis after arterial intervention in the patient""s artery is provided, comprising a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire, said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the present invention, an apparatus inserted into a sheath in a patent""s artery and guided by a guidewire within the patient""s artery for reducing restenosis after arterial intervention in the patient""s artery is provided, comprising a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire, said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end, said balloon catheter being adapted to be inserted into said sheath.
According to another aspect of the present invention, an apparatus guided by a guidewire within a patient""s artery for reducing restenosis after arterial intervention in the patient""s artery is provided, comprising a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending partially through said balloon catheter, said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end, said guidewire lumen having an entry port located at a distal end of said balloon catheter and an exit port located upon a circumferential surface of said balloon catheter.
According to another aspect of the present invention, an apparatus for reducing restenosis after arterial intervention in a patient""s-artery is provided, comprising a guidewire for insertion into the patient""s artery at least as far as a target area of the artery, a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire, said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the present invention, an apparatus guided by a guidewire within a patient""s artery for reducing restenosis after arterial intervention in the patient""s artery is provided, comprising a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire, said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the present invention, an apparatus to be inserted into a catheter for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising a radiation dose delivery wire with a radiation source encapsulated within its distal end, and a blind lumen open at its proximal end and sealed at its distal end, said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end and to be inserted into said catheter.
According to another aspect of the present invention, a method of reducing restenosis after arterial intervention in a patient""s artery is provided, comprising inserting a guidewire into the patient""s artery until a distal end of the guidewire is at least as far into the artery as a predetermined section of the artery, inserting the guidewire into a guidewire lumen of a balloon catheter with a blind lumen, inserting the balloon catheter with the blind lumen into the patient""s artery at least as far as the predetermined section of the artery, inserting a radiation dose delivery wire into said blind lumen in said balloon catheter, moving said radiation dose delivery wire a predetermined distance into the blind lumen of the balloon catheter for a predetermined period of time, and removing said radiation dose delivery wire from said blind lumen of said balloon catheter after said predetermined period of time.
According to another aspect of the instant invention an apparatus for use with a guidewire for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s artery, said balloon catheter having a radiation producing coating on an internal surface.
The radiation producing coating may include a material selected from the group consisting of Al-26, Sn-123, K-40, Sr-89, Y-91, Ir-192, Cd-115, P-32, Rb-86, I-125, Pd-103, and Sr-90, or any other material selected from Table 2, for example.
Regarding Tables 2-4, it is noted that the legend xe2x80x9cAxe2x80x9d refers to atomic mass, the half-life is given in years, days, hours, and minutes, where appropriate, a xe2x80x9cRad. Typexe2x80x9d (radiation type) B+ indicates emission of a positron particle, Bxe2x88x92 indicates the emission of a beta particle, and G indicates the emission of a gamma photon.
The radiation producing coating may comprise a lacquer, a glue, an acrylic, or a vinyl.
The balloon portion of the catheter may be formed of a plastic material such as polyethylene, PET, and nylon.
According to another aspect of the instant invention an apparatus for use with a guidewire for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s artery, said balloon catheter having a radiation producing coating on an exterior surface.
The radiation producing coating may include a material selected from the group consisting of Al-26, Sn-123, K-40, Sr-89, Y-91, Ir-192, Cd-115, P-32, Rb-86, I-125, Pd-103, and Sr-90, or any other material selected from Table 2, for example.
The radiation producing coating may comprise a lacquer, a glue, an acrylic, or a vinyl.
The balloon catheter may be formed of a plastic material chosen from the group consisting of polyethylene, PET, and nylon.
According to another aspect of the instant invention an apparatus for use with a guidewire for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s artery, said balloon catheter being formed of a flexible material including a radiation producing source.
The flexible material may be formed of a plastic material such as polyethylene, PET, and nylon.
The plastic material may be doped with said radiation producing source.
The radiation producing source may be chemically bonded to said plastic material by a covalent bond.
The radiation producing source may be bonded to said plastic material by an ionic bond.
The radiation producing source may be bonded to said plastic material by a biotin-avidin link.
The radiation producing source may be bonded to said plastic material by coextrusion.
According to another aspect of the instant invention a method for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising inserting a balloon catheter with a fluid delivery port connected thereto into the patient""s artery and inserting a radioactive fluid into the balloon catheter through the fluid delivery port.
The radioactive fluid may be selected from the group consisting of fluids containing Cu-61, Se-73, Co-55, Sc-44, Sr-75, Kr-77, Ga-68, In-110, Br-76, Ga-66, Ga-72, Sb-122, Na-24, Si-31, Ge-77, Ho-166, Re-188, Bi-212, Y-90, K-42, Ir-192, I-125, Pd-103, Sr-90, and radioactive sodium-chloride, or any other chemical compound formulated from the isotopes given in Table 3, for example.
According to another aspect of the instant invention an apparatus guided by a guidewire within a patient""s artery for receiving a radiation dose delivery wire with a radiation source encapsulated within its distal end and for reducing restenosis after arterial intervention in the patient""s artery is provided, comprising a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire, said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the present invention an apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation delivery wire into its proximal end; and means for moving the distal end of said radiation dose delivery wire to a predetermined position within said blind lumen for a predetermined period of time.
According to another aspect of the present invention an apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end; and a radiation blocking shield movable between the radiation source within the patient""s luminal structure and a user of the apparatus.
According to another aspect of the instant invention an apparatus inserted into a sheath in a luminal structure of a patient and guided by a guidewire within the patient""s luminal structure for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end; said balloon catheter being adapted to be inserted into said sheath; and means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.
According to another aspect of the instant invention an apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending partially through said balloon catheter; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end; said guidewire lumen having an entry port located at a distal end of said balloon catheter and an exit port located upon a circumferential surface of said balloon catheter.
According to another aspect of the instant invention an apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; and a catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end.
According to another aspect of the instant invention an apparatus with a catheter to be inserted into a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; and a blind lumen open at its proximal end and sealed at its distal end; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end and to be inserted into said catheter.
According to another aspect of the instant invention an apparatus for use with a guidewire inserted in a luminal structure of a patient for treating a disease process is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s luminal structure; said balloon catheter having a radiation producing coating on an internal surface.
According to another aspect of the instant invention an apparatus for use with a guidewire inserted into a luminal structure of a patient for treating a disease process is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s luminal structure; said balloon catheter having a radiation producing coating on an exterior surface.
According to another aspect of the instant invention an apparatus for use with a guidewire inserted into a luminal structure of a patient for treating a disease process is provided, comprising a balloon catheter with a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s luminal structure; said balloon catheter being formed of a flexible material including a radiation producing source.
According to another aspect of the instant invention a method for treating a disease process in a luminal structure of a patient is provided, comprising inserting a balloon catheter with a fluid delivery port connected thereto into the patient""s artery; inserting a radioactive fluid into the balloon catheter through the fluid delivery port.
According to another aspect of the instant invention an apparatus guided by a guidewire within a luminal structure of a patient for receiving a radiation dose delivery wire with a radiation source on its distal end and for treating a disease process is provided, comprising a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the instant invention an apparatus for use with a guidewire inserted into a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; and a balloon catheter with a blind lumen sealed at its distal end a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s luminal structure; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end.
According to another aspect of the instant invention an apparatus for use with a sheath and a guidewire inserted into a luminal structure of a patient for treating a disease process is provided, comprising a radiation dose delivery wire with a radiation source attached to its distal end; and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient""s luminal structure; said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end; said balloon catheter being adapted to be inserted into a sheath in the patient""s luminal structure surrounding said guidewire.
According to another aspect of the instant invention an apparatus inserted into a luminal structure of a patient for treating a disease process is provided, comprising a guidewire for insertion into the patient""s luminal structure at least as far as a target area of the luminal structure; a radiation dose delivery wire with a radiation source attached to its distal end; and a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire; said blind lumen being adapted to accept said radiation delivery wire into its proximal end.
According to another aspect of the instant invention a method of treating a disease process in a patient is provided, comprising inserting a guidewire into a luminal structure of the patient until a distal end of the guidewire is at least as far into the luminal structure as a predetermined section of the luminal structure; inserting the guidewire into a guidewire lumen of a balloon catheter with a blind lumen; inserting the balloon catheter with the blind lumen into the patient""s luminal structure at least as far as the predetermined section of the luminal structure; inserting a radiation dose delivery wire into said blind lumen in said balloon catheter; moving said radiation dose delivery wire into said blind lumen in said balloon catheter; moving said radiation dose delivery wire a predetermined distance into the blind lumen of the balloon catheter for a predetermined period of time; and removing said radiation dose delivery wire from said blind lumen of said balloon catheter after said predetermined period of time.
According to another aspect of the instant invention a method for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising inserting a balloon catheter with a fluid delivery port connected thereto into the patient""s artery, and inserting a radioactive fluid into the balloon catheter through the fluid delivery port, said radioactive fluid being selected from the group consisting of radioisotopes that decay with emission of beta plus or beta minus radiation, that have a half-life of between approximately 1 and 72 hours, that have an average decay energy of approximately 500-2000 keV, and that have radiation intensity of greater than or equal to approximately 50%, said radiation intensity being measured in % per decay. The radioisotopes may be non-iodine and non-phosphorus based.
According to another aspect of the instant invention an apparatus for reducing restenosis after arterial intervention in a patient""s artery is provided, comprising a balloon catheter with a fluid delivery port connected thereto, and a radioactive fluid inserted into the balloon catheter through the fluid delivery port, said radioactive fluid being selected from the group consisting of radioisotopes that decay with emission of beta plus or beta minus radiation, that have a half-life of between approximately 1 and 72 hours, that have an average decay energy of approximately 500-2000 keV, and that have radiation intensity of greater than or equal to approximately 50%, said radiation intensity being measured in % per decay. The radioisotopes may be non-iodine and non-phosphorus based.
According to another aspect of the instant invention a dual-balloon catheter for treating a disease process in a luminal structure of a patient is provided, comprising an inner balloon, an outer balloon substantially concentric with and substantially surrounding the inner balloon, an inner balloon fluid delivery lumen in fluid connection with the inner balloon, and an outer balloon fluid delivery lumen in fluid connection with the outer balloon.
According to another aspect of the instant invention a method for treating a disease process in a luminal structure of a patient is provided, comprising inserting into the luminal structure a dual-balloon catheter including an inner balloon, an outer balloon substantially concentric with and substantially surrounding the inner balloon, an inner balloon fluid delivery lumen in fluid connection with the inner balloon, and an outer balloon fluid delivery lumen in fluid connection with the outer balloon, and inserting a radioactive fluid into at least one of the inner balloon and the outer balloon through the inner balloon fluid delivery lumen and the outer balloon fluid delivery lumen, respectively.
According to another aspect of the instant invention an indiflator for inserting fluid into a balloon catheter is provided, comprising an elongated tube for holding the fluid, the elongated tube having a first end and a second end, the first end of the elongated tube having a wall across the tube with a port therein for providing a fluid passage between an interior of the tube and an exterior of the tube, a plunger assembly including a plunger head with a first face and a second face and a plunger stem having first and second ends, the plunger head being adapted to slide within the tube and being connected to the first end of the plunger stem, lock means disposed at the second end of the tube for accepting and releasably locking the plunger stem, the second end of the plunger stem being disposed outside the tube, and a pressure valve disposed adjacent the second end of the plunger stem and being operatively connected to a pressure transducer on the second face of the plunger head facing the first end of the tube, whereby the pressure valve displays a pressure in an area of the tube between the first end of the tube and the second face of the plunger head.
These and other advantages will become apparent from the detailed description, accompanying the claims and attached drawing figures.